|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant|| MEDTRONIC INC.|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to the manual for the model 8840 nvision clinician programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (emi) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other medtronic labeling for external programming devices.